Generic Name: inotersen (Subcutaneous route)
Medically reviewed by Drugs.com. Last updated on Dec 23, 2019.
ThrombocytopeniaInotersen causes reductions in platelet count that may result in sudden and unpredictable thrombocytopenia, which can be life-threatening.Testing prior to treatment and monitoring during treatment is required.GlomerulonephritisInotersen can cause glomerulonephritis that may require immunosuppressive treatment and may result in dialysis-dependent renal failure.Testing Prior to treatment and monitoring during treatment is required.TEGSEDI is only available through a restricted distribution program call the TEGSEDI REMS Program .
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Endocrine-Metabolic Agent
Uses for Tegsedi
Inotersen injection is used to treat polyneuropathy (nerve disease) of hereditary transthyretin-mediated amyloidosis.
This medicine is available only under a restricted distribution program called Tegsedi™ REMS (Risk Evaluation and Mitigation Strategy) Program.
Before using Tegsedi
Appropriate studies have not been performed on the relationship of age to the effects of inotersen injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inotersen injection in the elderly. However, elderly patients are more likely to have serious unwanted effects (including heart failure, chills, myalgia, or pain in the arms or legs), which may require caution in patients receiving this medicine.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with medicines
- Amtolmetin Guacil
- Choline Salicylate
- Dabigatran Etexilate
- Drotrecogin Alfa
- Flufenamic Acid
- Mefenamic Acid
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Protein C
- Salicylic Acid
- Sodium Salicylate
- Tiaprofenic Acid
- Tolfenamic Acid
Interactions with food/tobacco/alcohol
Other medical problems
- Bleeding problems or
- Kidney disease or
- Liver disease or
- Stroke, history of or
- Vitamin A deficiency—Use with caution. May make these conditions worse.
- Glomerulonephritis (swelling of the kidneys), history of or
- Thrombocytopenia (low platelet count)—Use is not recommended in patients with these conditions.
Proper use of Tegsedi
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach, thighs, or upper arms. You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, or hard, or with scars or tattoos.
It is very important that you understand the requirements of the Tegsedi™ REMS program, and become familiar with the Tegsedi™ Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.
Allow the medicine to warm to room temperature for 30 minutes before you use it. Do not warm it in any other way.
Check the liquid in the prefilled syringe or autoinjector. It should be colorless or slightly yellow. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it. Do not shake.
Do not remove the needle cap from the prefilled syringe until you are ready to use it.
You might not use all of the medicine in each prefilled syringe. Use each prefilled syringe only one time. Do not save an open syringe.
- For injection dosage form (solution):
- For polyneuropathy of hereditary transthyretin-mediated amyloidosis:
- Adults—284 milligrams (mg) injected under the skin once a week.
- Children—Use and dose must be determined by your doctor.
- For polyneuropathy of hereditary transthyretin-mediated amyloidosis:
If you miss a dose of this medicine, use it as soon as you can. If your next dose is within 2 days, skip the missed dose and go back to your regular dosing schedule.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
You may store this medicine at room temperature for up to 6 weeks. Throw any unused medicine after 6 weeks.
Precautions while using Tegsedi
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Inotersen injection will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
This medicine may increase your risk for inflammatory or immune system problems, stroke, or arterial dissection (tear in the lining of a brain artery). Check with your doctor if you have confusion, difficulty in speaking, slow speech, inability to speak, inability to move the arms, legs, or facial muscles, double vision, headache, spasms in the legs, back pain, or weight loss.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
This medicine may decrease the vitamin A levels in the blood. Check with your doctor right away if blurred vision, difficulty with reading, difficulty seeing at night, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Tegsedi side effects
Check with your doctor immediately if any of the following side effects occur:
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- decreased frequency or amount of urine
- difficulty in moving
- dizziness or lightheadedness when getting up suddenly from a lying or sitting position
- fast, slow, or irregular heartbeat
- general feeling of discomfort or illness
- increased blood pressure
- increased thirst
- joint pain
- loss of appetite
- lower back or side pain
- muscle pain or stiffness
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- runny nose
- sore throat
- swelling of the face, fingers, arms, or lower legs
- tightness of the chest
- trouble breathing
- trouble sleeping
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- weight gain
- Chest pain
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- swollen joints
- Dry mouth
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More about Tegsedi (inotersen)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: miscellaneous metabolic agents
- FDA Approval History